RecruitingNot ApplicableNCT06453291

Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain

Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques

Sponsor

Iffat Anwar Medical Complex

Enrollment

100 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Low Back Pain (CLBP)

Summary

This clinical trial aims to assess the effectiveness of different clinical techniques in treating patients with chronic low back pain (CLBP). Two test groups will be included: one receiving conventional therapy (NSAIDs and other physical therapy techniques) and the other receiving a combination of neuromodulation and platelet-rich plasma (PRP) therapy. Chronic pain, persisting for more than three months, inhibits natural pathways like GABA and promotes excitatory pathways, leading to increased inflammation. The study hypothesizes that neuromodulation via the dorsal root ganglion (DRG) and PRP therapy will provide superior pain relief and functional improvement compared to conventional therapy.

Eligibility

Min Age: 40 YearsMax Age: 60 Years

Inclusion Criteria4

Adults aged 40-60 years.
Diagnosed with chronic low back pain persisting for more than three months.
Willingness to participate and comply with study procedures.
Ability to provide informed consent.

Exclusion Criteria6

Comorbidities.
Contagious and Non-Contagious Infections
Known hypersensitivity to study interventions.
Presence of severe psychiatric disorders.
Pregnancy or breastfeeding.
Participation in another clinical trial within the last 30 days.

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Interventions

DRUGNSAIDs (Nonsteroidal Anti-Inflammatory Drugs):

Objective: To reduce pain and inflammation associated with chronic low back pain. Medications: Ibuprofen, Naproxen, or Diclofenac. Dosage: Ibuprofen: 400-600 mg every 6-8 hours as needed. Naproxen: 250-500 mg twice daily as needed. Diclofenac: 50 mg three times daily as needed. Administration: Oral tablets. Duration: Daily use as prescribed, for the duration of the study. Monitoring: Regular follow-up visits to monitor pain levels, side effects, and adherence.

PROCEDUREStandard Physical Therapy

Objective: To improve mobility, strength, and reduce pain. Techniques: Stretching exercises. Strengthening exercises for core and back muscles. Manual therapy techniques. Postural training. Frequency: Twice a week sessions. Duration: 45-60 minutes per session. Monitoring: Progress will be assessed during each session and adjusted as necessary

PROCEDURENeuromodulation via Dorsal Root Ganglion (DRG):

Objective: To modulate excitatory pathways and reduce pain through targeted stimulation. Procedure: Placement of electrodes near the DRG. Application of pulsed radiofrequency (RF) at 42°C for 3-20 minutes. Frequency: Initial treatment: Once a week for the first month. Maintenance: Monthly sessions if needed. Duration: Each session lasts approximately 30-45 minutes. Monitoring: Pain levels and functional improvement will be assessed before and after each session.

PROCEDUREPlatelet-Rich-Plasma Therapy

Objective: To promote healing and reduce inflammation through the application of concentrated platelets. Procedure: Blood draw from the patient. Centrifugation to separate platelets. Injection of PRP into the affected area of the lower back. Frequency: Initial treatment: Once a week for the first three weeks. Follow-up: Additional injections may be given based on patient response and clinical judgment. Duration: Each session lasts approximately 30-45 minutes. Monitoring: Pain levels, inflammation markers, and functional improvement will be assessed before and after each injection.